COIC Policy Definitions

Conflict of Interest or Commitment exists as determined by University. This determination warrants management.

Covered Person's activity or Interest may represent actual or potential Conflict of Interest or Commitment, but needs analysis. If Apparent Conflict is ruled nonexistent, perception may still warrant explanation and documentation.

The Covered Person's direct supervisor. Board of Trustees serves as Appropriate Authority for the President.

A Covered Person's annual attestation to the Standards of Conduct and disclosure of external activities and Interests to the University.

An external relationship or interest that influences Covered Person's professional judgment in University teaching, Research, outreach, or public service. The term also includes situation in which Covered Person engages in a Non-University Commitment that may interfere with fulfillment of obligations to University. Examples may include outside employment, pro bono or volunteer work, and government service in public interest and obligations to share improperly information with, or to withhold information from, the University or a funding agency.

The office responsible for collecting and reviewing submitted ADFs. COIC Office fulfills the following duties:

• preserve files on all ADFs at University;
• keep databases for tracking disclosures and disclosure dates;
• keep administrative files for CRB;
• screen disclosures for completeness before starting review;
• act as a resource for Covered Persons on general regulatory information, guidance with forms, and aid in preparing ADF;
• provide reports certifications, and assurances for federal, state, departmental- and unit-wide surveying of disclosure compliance;
• provide sanctioned reports or certifications for external sponsors or agencies, when necessary;
• preserve information on federal regulations about conflicts of interest in research;
• provide education about the COI process and regulations to the University community;
• provide education opportunities to CRB members; and
• conduct quality assurance and quality improvement for the CRB.

The Vice President for Risk, Audit and Compliance, who is responsible for implementation and enforcement of COIC policy, serves as the COIC Officer and reports directly to President. COIC Officer is responsible for developing and issuing this policy. COIC Officer is responsible for ensuring compliance with all federal, state and local requirements about conflicts of interest. COIC Officer shall report yearly to President and Board of Trustees under this policy. COIC Officer may delegate responsibilities under this policy to COIC Office.

Panel named by COIC Officer to evaluate potential COIC, review reconsideration requests, and review information about noncompliance. Members include both faculty and administrative staff. The CRB is chaired by the COIC Director (who only votes to break a tie vote).

All University faculty, administrators, staff, and any other individuals (full or part-time, paid or unpaid) participating in academic, business, clinical, and Research or scholarly activities for University.

Any domestic or foreign, public or private business, organization, corporation, partnership, proprietorship, limited liability company, or firm, regardless of whether organized for profit or as a nonprofit entity. The term does not include University, University Research Foundation, or University Athletic Association

Any condition in which an SFI could directly and significantly affect the design, conduct, or reporting of Research.

A University's report of a financial conflict of interest to a Public Health Service Awarding Component.

Anything of monetary value including, but not limited to: direct or indirect interest in business consisting of any stock, stock option, or similar ownership interest in such business, but excluding any interest arising solely by reason of investment in such business by a mutual fund, pension, or other institutional investment fund over which the Covered Person does not exercise control; or receipt of, or the right or expectation to receive, any income in one or more of: consulting fee, honorariums, salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty gained from licensing of technology, or other processes or products, rent, capital gain, or any other form of compensation. FI may arise from (nonexclusive examples):

• Compensation, including wages, salaries, commissions, professional fees, or fees for business referrals;
• Consulting, including commercial and professional consulting and service arrangements, scientific and technical advisory board memberships, or serving as an expert witness in litigation;
• Services provided in exchange for honorariums including travel expense repayments;
• Research funding or other forms of Research Support;
• Investment in the form of stock or bond ownership;
• Business ownership or partnership interests;
• Patents, copyrights, and other intellectual property interests;
• Seeking or negotiating for prospective employment or business; or
• Gifts, including travel.

An effort directly or indirectly organized, managed, or funded by a foreign government or institution to recruit science and technology professionals or students (regardless of citizenship or national origin, and whether having a full-time or part-time position). Some such programs operate with the intent to import or otherwise acquire from abroad, sometimes through illicit means, proprietary technology or software, unpublished data and methods, and intellectual property to further the military modernization goals and/or economic goals of a foreign government. Many, but not all, programs aim to incentivize the targeted individual to relocate physically to the foreign state for the above purpose. Some programs allow for or encourage continued employment at United States research facilities or receipt of Federal research funds while concurrently working at and/or receiving compensation from a foreign institution, and some direct participants not to disclose their participation to United States entities. Compensation could take many forms including cash, research funding, complimentary foreign travel, honorific titles, career advancement opportunities, promised future compensation, or other types of remuneration or consideration, including in-kind compensation

Means 80% or more full-time equivalent and for which employment continues for six months or more.

Means person qualifies for authorship but not listed as an author or recognized on a publication. Ghostwriting occurs when a commercial entity writes an article or presentation and a Covered Person is named as an author. This includes papers or presentations featuring data that were simply presented to the named author (without the opportunity for that person to analyze, directly, perform calculations, review or question the data).

Means person does not qualify for authorship but named as an author.

Anything Covered Person receives while not giving equal or greater consideration within 90 days. Term^[1] includes, not limited to:

• food or drink,
• membership dues,
• plants, flowers, floral arrangements,
• transport and lodging, a preferential rate,
• use of property,
• forgiveness of a debt or loan,
• entrance fees, admission fees or tickets to events, performances, or facilities,
• charged services provided free, or
• other similar service having an attributable value not already provided for in this definition.

Anything of value given to Covered Person for speech or written item (other than a book, intended to be published). Term does not include payments for outside employment or payments for Covered Person's public duties. Term does not include payment of reasonable transport, lodging, registration fee, or food and drink expenses for Covered Person and spouse at honorarium event.

A condition compromising or seemingly compromising Institutional Official or University's decision making. ICOIs may arise when (non-exhaustive list):

• Institutional official Official with significant Significant financial Financial interest Interest in business Entity is in position to act for University that may benefit business Entity;
• University licenses invention to business Entity and holds an Institutional Financial Interest (i.e. royalty or equity interests) in Entity;
• Vendor gives a Gift to the University that creates an Institutional Financial Interest;
• University holds investments in business Entity that has financial or business affiliation with University;
• University enters commercial transaction compromising or seemingly compromising University's missions, or institutional reputation; or
• University has significant Institutional financial Financial interest Interest in business Entity with commercial interests affected by research conducted at University.

Institutional Financial Interests include, but are not limited to:

• Royalty arrangements: payments, including royalty payments and licensing fees, resulting from technology transfer, licensing, and business activities that exceed $100,000 in the preceding twelve-month period from a single entity;
• Non-publicly traded equity (equity and ownership interests of any amount in any for-profit entity that is not publicly traded);
• Publicly-traded equity (equity and ownership interests valued at greater than $100,000 in the preceding twelve (12) month period in any publicly-traded, for-profit entity, except for equity held in the University's endowment); and
• Gifts above one million dollars from for-profit entity or philanthropic unit associated with for-profit entity^[2].

Institutional Financial Interest shall also mean the following non-exhaustive financial or business interests of Institutional Officials (and those of the Institutional Official's spouse or partner):

• Equity or ownership interests in publicly-traded, for-profit Entities if the value exceeds $25,000 in the preceding twelve (12) month period. Not included are equity or ownership interests in mutual funds and retirement accounts (as long as the University Official does not directly control the investment decisions made in these investment vehicles );
• Equity (including stock, options, warrants), ownership, or founders' interests of any amount in non-publicly traded Entities;
• Income, including royalties, equity, consulting fees, honorariums and gifts or other payments, from for-profit Entities that, in the aggregate, exceed $25,000 from entity in preceding twelve-month period;
• Fiduciary role with for-profit Entity, regardless of compensation or income, such as service on the board of directors, management role in company or partnership (for example, President, CEO, COO, CRO, CSO or Treasurer).
• Fiduciary role with nonprofit entity that could reasonably lead to potential ICOI.

The committee responsible for the review and approval of teaching and research conducted under the auspices of the University involving animals.

The committee responsible for the review and approval of research conducted under the auspices of the University involving biological materials.

The board responsible for the review and approval of human subject research conducted under the auspices of the University.

People with direct authority over faculty and staff appointments, salaries, promotions, signatory authority, or division of institutional resources, such as assignment of graduate students or other trainees, progress or promotion of students, funding or space, for faculty who are conducting research. Term includes anyone holding administrator positions, even temporarily. Term includes, but not limited to individuals serving as:

• Deans, Associate Deans, and Assistant Deans
• Institute and Center Directors
• University Counsel
• University Compliance Officers
• Director of Audit Services
• Provost, Vice Provosts, Associate Vice Provosts, and Assistant Vice Provosts
• President, Executive Vice Presidents, Senior Vice Presidents, Vice Presidents, Associate Vice Presidents, and Assistant Vice Presidents
• Department Heads
• Directors of Sponsored Programs, Technology Transfer, Research Integrity, Human Subjects Protection

and chairs of the:

• Institutional Review Board
• Institutional Biosafety Committee
• Institutional Animal Care and Use Committee
• Conflict Review Board

and other similar committees created in the future.

A Covered Person's direct (e.g. ownership) or indirect (e.g. receipt by Covered Person of direct financial) gain, benefit, monetary value, right, claim, or share.

Textbooks, software, courseware, and laboratory equipment.

A person, regardless of title, position, pay, role, or responsibilities, with ability to decide independently design, conduct, or reporting of University Research. Term does not include people who perform only incidental or isolated tasks related to project.

1. any program,position, or activity that includes compensation in the form of cash, in-kind compensation, including research funding, promised future compensation, complimentary foreign travel, things of non de minimis value, honorific titles, career advancement opportunities, or other types of remuneration or consideration directly provided by a foreign country at any level (national,provincial, or local) or their designee, or an entity based in, funded by, or affiliated with a foreign country, whether or not directly sponsored by the foreign country, to the targeted individual, whether directly or indirectly stated in the arrangement, contract, or other documentation at issue, in exchange for the individual—
   1. engaging in the unauthorized transfer of intellectual property, materials, data products, or other nonpublic information owned by a United States entity or developed with a Federal research and development award to the government of a foreign country or an entity based in, funded by, or affiliated with a foreign country regardless of whether that government or entity provided support for the development of the intellectual property, materials, or data products;
   2. being required to recruit trainees or researchers to enroll in such program, position, or activity;
   3. establishing a laboratory or company, accepting a faculty position, or undertaking any other employment or appointment in a foreign country or with an entity based in, funded by, or affiliated with a foreign country if such activities are in violation of the standard terms and conditions of a Federal research and development award;
   4. being unable to terminate the foreign talent recruitment program contract or agreement except in extraordinary circumstances;
   5. through funding or effort related to the foreign talent recruitment program, being limited in the capacity to carry out a research and development award or required to engage in work that would result insubstantial overlap or duplication with a Federal research and development award;
   6. being required to apply for and successfully receive funding from the sponsoring foreign government's funding agencies with the sponsoring foreign organization as the recipient;
   7. being required to omit acknowledgment of the recipient institution with which the individual is affiliated, or the Federal research agency sponsoring the research and development award, contrary to the institutional policies or standard terms and conditions of the Federal research and development award;
   8. being required to not disclose to the Federal research agency or employing institution the participation of such individual in such program, position, or activity; or
   9. having a conflict of interest or conflict of commitment contrary to the standard terms and conditions of the Federal research and development award; and
2. a program that is sponsored by—
   1. a foreign country of concern or an entity based in a foreign country of concern, whether or not directly sponsored by the foreign country of concern;
   2. an academic institution on the list developed under section 1286(c)(8) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 ( 10 U.S.C. 2358 note; Public Law115-232 ); or
   3. a foreign talent recruitment program on the list developed under section 1286(c)(9) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 ( 10 U.S.C. 2358 note; 1 Public Law 115-232 ).

Taking action to address identified COIC. Term includes reducing or removing the COIC, to ensure that affected activity is free from bias.

A written plan for management, reduction, or elimination of identified conflicts of interest and commitment.

A written report filed by University when results of Retrospective Review show bias occurred because of unreported or unmanaged FCOI. Mitigation Report includes:

• Findings of Retrospective Review;
• Description of impact of bias on Research; and
• University's plan of action or actions taken to remove or mitigate effect of bias^[3].

Outside (non-University) consulting or other activity, paid or unpaid, beyond work assignment of Covered Person's University Responsibilities or employment.

Situation where because of relationships with a parent company, affiliate, or subsidiary organization, the non-Federal entity is unable or appears to be unable to be impartial in conducting a procurement action involving a related organization. Situation in which a person cannot give unbiased aid or advice to the Government, or the person's objectivity in performing the contract work is, or might be, otherwise undermined, or a person has an unfair competitive advantage.

The decision to overrule the CRB recommendation requires review and consideration by the overrule panel. The panel consists of the COIC Officer in conjunction with the Provost and either the Executive Vice President for Research and Innovation (in research matters) or the Chief Financial Officer (for business matters).

To be part of the University activity in any capacity, including, but not limited to, serving as the PI, co-investigator, Research collaborator, or provider of direct services or patient care. Term does not apply to Covered Persons who provide mainly technical or advisory Support and have no direct access to data or control over its collection or analysis. Term also does not apply to study participants, unless they are in position to influence study's results or have privileged information about results.

Use University resources for personal or private purposes or personal or private financial or non-financial benefits. Personal or private benefits may include, but not limited to, cash, profits, securities, Gifts, performed work, or sex.

A person over 18 years old, and, if blood Relative (or Relative by adoption or marriage) must be of same or younger generation as Covered Person (as used in KRS 391.010), and, must be living in Covered Person's household (for at least 12 months), and financially interdependent (for example, have a joint checking account or a joint mortgage) for 12 months or longer, and be unmarried.

A submission in writing by the Covered Person requesting the CRB to reconsider one or more clauses in the approved management plan. The request should include, at a minimum, the clause(s) needing change, a reason of why the approved Management Plan will not work, and a proposed revision to the approved management clause(s).

Directly and significantly associated with Covered Person' Research associated with Research based on topic, use of products, potential for an increase in the value of SFI, or company in which SFI is held.

Anyone related to a Covered Person in the following ways, and includes those within these categories who are referred to as adopted, step-, foster, grand-, half-, in-law, spouse of, or great-: parent, child or ward, sibling, uncle or aunt, first cousin, nephew or niece, spouse, or domestic partner, or significant other.

Salary or any payment for services not identified as salary (e.g., consulting fees, honoraria, paid authorship, travel reimbursement); equity interest includes any stock, stock option, or other ownership Interest, as determined through reference to public prices or other reasonable measures of fair market value.

Research and Development. Research means a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. This definition encompasses basic and applied research, including research training activities not included in formal instruction and all development activities. Development is the systematic use of knowledge and understanding gained from research, directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes. For purposes of this policy, both research and development apply. A systematic investigation designed to develop or contribute to generalizable knowledge. Term encompasses basic and applied research, service and testing, and product development that may be published. Term includes any such condition for which research funding is available through grant, cooperative agreement, or contract, such as research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award or gift. Term also includes research activities that are not funded or sponsored.Gifts may be considered research projects needing COIC management when used for purposes related to Covered Person's Interests.

Review conducted by University when Investigator fails to report SFI in timely manner or when noncompliance with PHS regulation or approved Management Plan is discovered.

Project director or PI who significantly influences the design, conduct, or reporting of a project and anyone identified as Senior or Key Personnel in grant application, approved budget, progress report, or any other report filed by law or regulation.

FI consisting of one or more of following Interests of Covered Person (and those of the Covered Person's spouse or partner and dependent child[ren]) related to University Responsibilities:

• For publicly traded Entities, value of any Remuneration received from Entity in 12 months preceding disclosure combined with value of Equity Interest in Entity as of date of disclosure, when totaled, exceeds $5,000;
• For non-publicly traded Entities (including but not limited to private "start-up" companies, closely held corporations, partnerships or sole proprietorships), if either:
• a. the value of any Remuneration received from the Entity in the 12 months preceding the disclosure, when totaled, exceeds $5,000; or
• b. the Investigator holds any Equity Interest (i.e., there is no de minimis amount for Equity Interests in a non-publicly traded Entity) in the Entity;
• Income from intellectual property rights and interests (for example, patents, trademarks, copyrights) that exceeds $5,000 in previous 12 months; or
• Repaid or sponsored travel exceeding $5,000 from Entity in 12 months preceding disclosure^[4].

University of Louisville Research Foundation, and University of Louisville Athletic Association and any other affiliates added in the future.

Situation when a Covered Person is directly or indirectly through span of control responsible for supervising, directing, evaluating, or influencing the work activities, or job performance of another Covered Person.

Providing anything of value (for example, funds, supplies, equipment, staff, etc.), regardless of whether restricted or unrestricted.

The duration of a Covered Person's University employment, status as a student, or affiliation with the University.

Repaid or sponsored Travel related to Covered Person's University Responsibilities, when combined with other Remuneration from Entity meets $5,000 reporting threshold. Covered Persons do not disclose Travel repaid or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), academic teaching hospital, medical center, or Research institution affiliated with Institution of higher education.

A Covered Person's duties and responsibilities on behalf of the University. The activities outlined in an Covered Person's annual assignment or position description may include administration, teaching, Research (regardless of whether or not it is funded), Research consultation, and creative activities, course preparation, curriculum development, lectures, evaluation of student efforts, academic advising, committee meetings and memberships, service on panels such as University review boards or data and safety monitoring boards, public service to include service on advisory committee's or review panels, and any other activity assigned by the Covered Person's Appropriate Authority in accordance with University policies.

Entities and individuals who provide goods and services to the University. This term includes pharmaceutical company and medical equipment representatives, as well as equipment and service providers.